ClinicalTrials.gg
Active, not recruitingNCT03449251DEFINEUpdated Sep 30, 2026

A Series of Pilot Studies to Evaluate the haemoDynamic and mEtabolic Effects oF apelIn aNd rElaxin

A Phase 2 interventional study of Apelin and Relaxin in Cardiovascular Diseases and Type 2 Diabetes Mellitus, sponsored by Cambridge University Hospitals NHS Foundation Trust. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Cambridge University Hospitals NHS Foundation Trust · Phase 2, Interventional, and Other

Updated Sep 30, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Type two diabetes mellitus (T2DM) is a common, long term metabolic disorder characterised by hyperglycaemia (high blood glucose) resulting from insulin resistance and relative insulin insufficiency. The risk of developing insulin resistance and subsequently T2DM is increased by being overweight and also through a sedentary lifestyle. As the onset can be gradual, physiological damage may have occurred prior to diagnosis. Diabetes is associated with the development of microvascular complications (diabetic nephropathy, neuropathy, and retinopathy), and macrovascular complications (coronary artery disease, peripheral arterial disease, and stroke). While there are many treatments available for T2DM, these complications may still arise, leading to significant morbidity and mortality. There is therefore an urgent need to identify novel signalling pathways that may contribute to the development of diabetes related complications. The identification of these pathways may ultimately lead to the development of new therapies targeting better blood glucose control and preventing these subsequent complications.

Both animal and human studies have indicated that two endogenous peptides, apelin and relaxin both act as vasodilators in the human cardiovascular system and could also have beneficial action in T2DM. Therefore, we aim to carry out experimental medicine studies to test this hypothesis, and explore the signalling pathway in the human vascular system.

Read the detailed description

An extensive body of evidence demonstrates a direct association between T2DM and cardiovascular complications and mortality. Unfortunately, current therapies for diabetes have failed to be translated into improvements in cardiovascular outcomes, highlighting an urgent need to develop novel therapeutic strategies that can ultimately achieve the dual outcome of improving glycaemic control and improving cardiovascular function.

While the precise cellular mechanisms involved remain to be elucidated, we hypothesise that the apelin and relaxin pathways meet these two criteria and therefore are potential therapeutic targets in conditions of abnormal glucose metabolism and heart failure.

Apelin and relaxin are safe for parenteral use as they are naturally occurring peptide hormones, have a short half-life and will be rapidly cleared. They target endogenous receptors and post-receptor signalling, and have been used in human trials without any significant side effects reported.

02

Conditions studied

  • Cardiovascular Diseases
  • Type 2 Diabetes Mellitus

Keywords

  • Apelin
  • Relaxin
03

In context

Cardiovascular Diseases

5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.

This study's planned enrollment of 170 is above the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust is the lead sponsor of 171 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Healthy participants

  • Have given written to participate
  • Aged 18 to 70 years inclusive
  • Male or female
  • Current non-smoker
  • If female, either or on days 2-9 of menstrual cycle and negative pregnancy test performed on the day of the of visit
  • in range for studies 1 and 4: 18.5-24.9 kg/m2 with waist circumference lower than 88 centimetres (35 inches) for women or 102 cm (40 inches) for men, and/or body fat level less than 32 % for women or 25% for men
  • BMI in range for studies 2 and 3: 18.5-30.0 kg/m2 without limitations in waist circumference or body fat level

Overweight/obese participants

  • Have given written informed consent to participate
  • Aged 18 to 70 years inclusive
  • Male or female
  • Current non-smoker
  • If female, either postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test performed on the day of the of visit
  • BMI in range of 25-34.9 kg/m2 (inclusive) with either waist circumference higher than 88cm (35 inches) for women or 102 cm (40 inches) for men, and/or body fat levels in excess of 32% for women or 25% for men

Participants with type 2 diabetes mellitus

  • Have given written informed consent to participate
  • Aged 18 to 70 years inclusive
  • Male or female
  • Current non-smoker
  • If female, either postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test performed on the day of the of visit
  • BMI in range of 25-34.9 kg/m2 (inclusive) with either waist circumference higher than 88cm (35 inches) for women or 102 cm (40 inches) for men, and/or body fat levels in excess of 32% for women or 25% for men
  • Documented diagnosis of Type 2 Diabetes Mellitus, either diet controlled or treated with oral hypoglycaemic therapy

Exclusion criteria

Exclusion Criteria:

  • to any of the study drugs or
  • Systemic Hypertension (sustained BP >160/100mmHg) or hypotension (systolic BP below 90 mmHg)
  • Known heart disease
  • Implanted heart pace-maker or implantable cardioverter defibrillator (ICD)
  • Known active
  • Known renal failure (creatinine >140µmol/L)
  • Known neurological disease
  • History of Scleroderma (Study 4 only)
  • Current pregnancy, breast feeding
  • Use of vasoactive medications or NSAIDS/aspirin within 24 hours of study visits
  • Use of caffeine within 24 hours of study visits
  • Current involvement in the active treatment phase of other research studies, (excluding observations/non-interventional)
  • Second or third-degree AV block, sino-atrial block, sick sinus syndrome or sinus bradycardia
  • Known , or C
  • Needle phobia
  • Participants treated with formal anticoagulant therapy such as, but not limited to, heparin, warfarin or clopidogrel
  • Diagnosis of Type 1 Diabetes Mellitus or current usage of insulin or other injectable drugs for the treatment of diabetes such as but not limited to GLP1 agonists
  • \<18.5
  • Aged \<18 or >70 years
  • Any other clinical reason which may preclude entry in the opinion of the investigator
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Phase
Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
170 participants (estimated)

Study arms

  • Experimental
    Substudy 1A - Apelin

    In sub-study 1A Healthy participants will receive systemic infusions of Apelin to establish a dose range

    Drug: Apelin

  • Experimental
    Substudy 1B - Apelin/Normal Saline

    In sub-study 1B , individuals with Type 2 Diabetes and individuals with increase weight will receive systemic infusions of Apelin or Normal Saline

    Drug: Apelin · Drug: Normal saline

  • Experimental
    Substudy 2A - Relaxin/Normal Saline

    In sub-study 2A Healthy participants will receive intra-arterial infusions of Relaxin

    Drug: Relaxin · Drug: Normal saline

  • Experimental
    Substudy 2B - Relaxin

    In sub-study 2B Healthy participants will receive intra-arterial infusions of Relaxin followed by verapamil (on a background infusion of either LN Monomethyl Arginine or Normal Saline, to test effects on nitric oxide)

    Drug: Relaxin · Diagnostic Test: Verapamil · Diagnostic Test: LN Monomethyl arginine

  • Experimental
    Substudy 3A - Relaxin with Apelin/Saline

    In sub-study 3A Healthy participants will receive intra-arterial infusions of Relaxin (background infusion apelin/Normal Saline)

    Drug: Apelin · Drug: Relaxin · Drug: Normal saline

  • Experimental
    Substudy 3B - Apelin with Relaxin/Saline

    In sub-study 3B Healthy participants will receive intra-arterial infusions of Apelin (background infusion Relaxin/Normal Saline)

    Drug: Apelin · Drug: Relaxin · Drug: Normal saline

  • Experimental
    Substudy 4 - Apelin and Relaxin

    In sub-study 4 Healthy participants, Individuals with Type 2 Diabetes and Individuals with increase weight will receive systemic infusions of Normal saline, Relaxin, Apelin and relaxin

    Drug: Apelin · Drug: Relaxin

  • Experimental
    Substudy 5 - Relaxin/Saline

    In sub-study 5 Healthy participants will be allocated to 1 of 4 Relaxin dosing groups and will receive dorsal hand vein infusion of 3 incremental doses of Normal Saline/ D5W and Relaxin

    Drug: Relaxin · Drug: Normal saline

Interventions

  • DrugApelin

    Apelin is an endogenous peptide that activate a single G-protein couple receptor. Apelin inhibits insulin secretion, decreases glucose levels and increases insulin sensitivity.

  • Relaxin is RLN2 encoded endogenous peptide hormone, which binds to G protein coupled receptor RXFP1.

    Also known as: RLX

  • DrugNormal saline

    Vehicle

    Also known as: Saline

  • Diagnostic testVerapamil

    NO independent challenge agent

  • Diagnostic testLN Monomethyl arginine

    Basal NO synthase inhibitor

    Also known as: LNMMA

06

What researchers measure

Primary outcomes

  1. Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (Glucose)

    Glucose, in mmol/l

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  2. Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (C-Peptide)

    C-peptide, in pmol/L

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  3. Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (Glucagon)

    Glucagon, in pg/ml

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  4. Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (Insulin)

    Insulin, in pmol/L

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  5. Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (TNF-alpha)

    TNF-alpha, in pg/ml

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  6. Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants

    Glucose, in mmol/l

    Time frame: Visit 2 to visit 5, over a period of up to 14 weeks

  7. Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants

    C-peptide, in pmol/L

    Time frame: Visit 2 to visit 5, over a period of up to 14 weeks

  8. Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants

    Glucagon, in pg/ml

    Time frame: Visit 2 to visit 5, over a period of up to 14 weeks

  9. Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants

    Insulin, in pmol/L

    Time frame: Visit 2 to visit 5, over a period of up to 14 weeks

  10. Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants

    TNF-alpha, in pg/ml

    Time frame: Visit 2 to visit 5, over a period of up to 14 weeks

  11. Sub-study 2a: Change in forearm blood flow parameters in healthy participants after infusion of relaxin (Absolute Flow)

    Absolute flow in the infused arm, in mg/dL/min

    Time frame: Within visit 2, over a period of up to 4 weeks

  12. Sub-study 2a: Change in forearm blood flow parameters in healthy participants after infusion of relaxin (Percentage Change)

    Percentage change in the infused arm, in %

    Time frame: Within visit 2, over a period of up to 4 weeks

  13. Sub-study 2a: Change in forearm blood flow parameters in healthy participants after infusion of relaxin (Ratio)

    Ratio, expressed as a number (no units as this is a ratio)

    Time frame: Within visit 2, over a period of up to 4 weeks

  14. Sub-study 2b: Change in forearm blood flow parameters in healthy participants after infusion of relaxin in the presence of L-NMMA or normal saline

    Ratio; absolute flow and percentage change in the infused arm

    Time frame: Visit 2 to visit 3, over a period of up to 10 weeks

  15. Sub-study 2b: Change in forearm blood flow parameters in health participants after infusion of verapamil in the presence of L-NMMA or normal saline (Ratio)

    Ratio; expressed as a number (no units as this is a ratio)

    Time frame: Visit 2 to visit 3, over a period of up to 10 weeks

  16. Sub-study 2b: Change in forearm blood flow parameters in health participants after infusion of verapamil in the presence of L-NMMA or normal saline (Absolute Flow)

    Absolute flow in the infused arm, in mg/dL/min

    Time frame: Visit 2 to visit 3, over a period of up to 10 weeks

  17. Sub-study 2b: Change in forearm blood flow parameters in health participants after infusion of verapamil in the presence of L-NMMA or normal saline (Percentage Change)

    Percentage change in the infused arm, In %

    Time frame: Visit 2 to visit 3, over a period of up to 10 weeks

  18. Sub-Study 3a: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial relaxin in the presence of apelin

    Ratio; absolute flow and percentage change in the infused arm

    Time frame: Visit 2 to visit 3, over a period of up to 10 weeks

  19. Sub-Study 3a: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial relaxin in the presence of apelin (Ratio)

    Ratio, expressed as a number (no units as this is a ratio)

    Time frame: Visit 2 to visit 3, over a period of up to 10 weeks

  20. Sub-Study 3a: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial relaxin in the presence of apelin (Absolute Flow)

    Absolute flow in the infused arm, in mg/dL/min

    Time frame: Visit 2 to visit 3, over a period of up to 10 weeks

  21. Sub-Study 3a: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial relaxin in the presence of apelin (Percentage Change)

    Percentage change in the infused arm, In %

    Time frame: Visit 2 to visit 3, over a period of up to 10 weeks

  22. Sub-Study 3b: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial apelin in the presence of relaxin (Ratio)

    Ratio, expressed as a number (no units as this is a ratio)

    Time frame: Visit 2 to visit 3, over a period of up to 10 weeks

  23. Sub-Study 3b: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial apelin in the presence of relaxin (Absolute Flow)

    Absolute flow in the infused arm, in mg/dL/min

    Time frame: Visit 2 to visit 3, over a period of up to 10 weeks

  24. Sub-Study 3b: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial apelin in the presence of relaxin (Percentage Change)

    Percentage change in the infused arm, In %

    Time frame: Visit 2 to visit 3, over a period of up to 10 weeks

  25. Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin (Glucose)

    Glucose, in each of the groups, in mmol/L

    Time frame: Visit 2 to Visit 4, over a period of up to 8 weeks

  26. Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin (C-peptide)

    C-peptide, in each of the groups, in pmol/L

    Time frame: Visit 2 to Visit 4, over a period of up to 8 weeks

  27. Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin (Glucagon)

    glucagon, in each of the groups,in pg/ml

    Time frame: Visit 2 to Visit 4, over a period of up to 8 weeks

  28. Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin (Insulin)

    Insulin, in each of the groups, in pmol/L

    Time frame: Visit 2 to Visit 4, over a period of up to 8 weeks

  29. Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin (TNF-alpha)

    TNF-alpha, in each of the groups, in pg/ml

    Time frame: Visit 2 to Visit 4, over a period of up to 8 weeks

  30. Sub-study 5: Change in hand vein diameter after relaxin infusion in healthy participants

    Hand vein Demeter is measured using Aellig dorsal hand vein technique

    Time frame: Visit 2

Secondary outcomes

  1. Sub-study 1a: Changes in parameters of cardiovascular haemodynamics in healthy participants after infusion of apelin (Echocardiography)

    Cardiac output measured by Echocardiography, in L/min

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  2. Sub-study 1a: Changes in parameters of cardiovascular haemodynamics in healthy participants after infusion of apelin (Innocor)

    Cardiac output measured by Innocor, in L/min

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  3. Sub-study 1a: Changes in parameters of cardiovascular haemodynamics in healthy participants after infusion of apelin (Bioimpedance)

    Cardiac output measured by bioimpedance, in L/min

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  4. Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin (Echocardiography)

    Cardiac output measured by Echocardiography, in L/min

    Time frame: VIsit 2 to visit 4, over a period of up to 8 weeks

  5. Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin (Innocor)

    Cardiac output measured by Innocor, in L/min

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  6. Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin (Bioimpedance)

    Cardiac output measured by bioimpedance, in L/min

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  7. Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin,after a mixed meal challenge (Echocardiography)

    Cardiac output measured by Echocardiography, in L/min

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  8. Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin, after a mixed meal challenge (Innocor)

    Cardiac output measured by Innocor, in L/min

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  9. Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin,after a mixed meal challenge (Bioimpedance)

    Cardiac output measured by bioimpedance, in L/min

    Time frame: VIsit 2 to visit 4, over a period of up to 8 weeks

  10. Sub-study 1b: Changes in markers of glucose homeostasis after infusion of apelin in obese/overweight and T2DM, after a mixed meal challenge (Clugose)

    Glucose, in mmol/L

    Time frame: Visit 2 to visit 5, over a period of up to 14 weeks

  11. Sub-study 1b: Changes in markers of glucose homeostasis after infusion of apelin in obese/overweight and T2DM, after a mixed meal challenge (C-peptide)

    C-peptide, in pmol/L

    Time frame: Visit 2 to visit 5, over a period of up to 14 weeks

  12. Sub-study 1b: Changes in markers of glucose homeostasis after infusion of apelin in obese/overweight and T2DM, after a mixed meal challenge (Glucagon)

    Glucagon, in pg/ml

    Time frame: Visit 2 to visit 5, over a period of up to 14 weeks

  13. Sub-study 1b: Changes in markers of glucose homeostasis after infusion of apelin in obese/overweight and T2DM, after a mixed meal challenge (Insulin)

    Insulin, in pmol/L

    Time frame: Visit 2 to visit 5, over a period of up to 14 weeks

  14. Sub-study 1b: Changes in markers of glucose homeostasis after infusion of apelin in obese/overweight and T2DM, after a mixed meal challenge (TNF alpha)

    TNF alpha, in pg/ml

    Time frame: Visit 2 to visit 5, over a period of up to 14 weeks

  15. Sub-study 2b: Change in forearm blood flow parameters after infusion of verapamil in the presence of L-NMMA or saline (Ratio)

    Ratio,expressed as a number (no units as this is a ratio)

    Time frame: Visit 2 to visit 3, over a period of up to 10 weeks

  16. Sub-study 2b: Change in forearm blood flow parameters after infusion of verapamil in the presence of L-NMMA or saline (Absolute Flow)

    Absolute flow in the infused arm, in mg/dL/min

    Time frame: Visit 2 to visit 3, over a period of up to 10 weeks

  17. Sub-study 2b: Change in forearm blood flow parameters after infusion of verapamil in the presence of L-NMMA or saline (Percentage Change)

    Percentage change in the infused arm, In %

    Time frame: Visit 2 to visit 3, over a period of up to 10 weeks

  18. Sub-study 4: Change in cardiovascular haemodynamics after infusion of relaxin (Echocardiography)

    Cardiac output measured by Echocardiography, in L/min

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  19. Sub-study 4: Change in cardiovascular haemodynamics after infusion of relaxin (Bioimpedance)

    Cardiac output measured by bioimpedance, in L/min

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  20. Sub-study 4: Change in cardiovascular haemodynamics after infusion of relaxin (Innocor)

    Cardiac output measured by Innocor, in L/min

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  21. Sub-study 4: Change in cardiovascular haemodynamics after combined infusion of relaxin and apelin (Echocardiography)

    Cardiac output measured by Echocardiography, in L/min

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  22. Sub-study 4: Change in cardiovascular haemodynamics after combined infusion of relaxin and apelin (Bioimpedance)

    Cardiac output measured by bioimpedance, in L/min

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  23. Sub-study 4: Change in cardiovascular haemodynamics after combined infusion of relaxin and apelin (Innocor)

    Cardiac output measured by Innocor, in L/min

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  24. Sub-study 4: Change in glucose homeostasis after combined infusion of relaxin and apelin (Glucose)

    Glucose, in mmol/L

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  25. Substudy 4: Change in glucose homeostasis after combined infusion of relaxin and apelin (C-peptide)

    C-peptide, in pmol/L

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  26. Sub-study 4: Change in glucose homeostasis after combined infusion of relaxin and apelin (Glucagon)

    Glucagon, in pg/ml

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  27. Sub-study 4: Change in glucose homeostasis after combined infusion of relaxin and apelin (Insulin)

    Insulin, in pmol/L

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

  28. Sub-study 4: Change in glucose homeostasis after combined infusion of relaxin and apelin (TNF alpha)

    TNF alpha, glucose homeostasis

    Time frame: Visit 2 to visit 4, over a period of up to 8 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2018 (actual). Primary completion is estimated for Dec 2026, 105 months after the start.

Of 60 non-industry phase 2 interventional studies under Cardiovascular Diseases, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 62. This study's planned 105 months is above that.

Counting every sponsor, half of 84 studies reached it within 28 months; a quarter within 16 and three quarters within 59.

Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 30, 2026: primary completion Sep 2025 → Dec 2026 and completion Sep 2025 → Dec 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Feb 6, 2018
First posted
Feb 28, 2018
StartActual
Mar 28, 2018
Primary completionEst.
Dec 2026was Sep 2025
CompletionEst.
Dec 2026was Sep 2025
Last update
Sep 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Sep 2025→Dec 2026
Sep 30, 2026
Study completion
Sep 2025→Dec 2026
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Primary completion Sep 2025→Dec 2026
    Study completion Sep 2025→Dec 2026
    + 3 other changes: index terms, verification date and responsible party

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03449251
Responsible party
Joseph Cheriyan, MBChB, MA, FRCP, FESC, FACC (Consultant Physician & Clinical Pharmacologist/Assoc Lecturer, Cambridge University Hospitals NHS Foundation Trust) — Principal investigator
First posted
Feb 28, 2018
Start date
Mar 28, 2018
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 30, 2026

Study contacts

Joseph Cheriyan, MBCHB, FRCP
principal investigator · Cambridge University Hospitals NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Apelin · Relaxin

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