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RecruitingNCT07829380COGENTUpdated Sep 21, 2026

The Cardiovascular-Cognitive Health Initiative

An interventional study of Structured cognitive and cardiovascular interventions in Cognitive Impairment, sponsored by National Heart Centre Singapore. Recruiting at 4 sites in Singapore. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by National Heart Centre Singapore · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
5,000
Allocation
Randomized
Ages
21 Years to 99 Years
Sex
All
01

Study summary

This study aims to understand how memory and thinking abilities (cognition) are affected in patients with heart conditions, and to find out if early detection and interventions can improve health outcomes.

Read the detailed description

Cardiovascular disease (CVD) and cognitive impairment frequently coexist in aging populations and accelerate each other's deterioration through shared vascular and neurobiological pathways.

Primary objectives:

i. To determine the prevalence and profile of cognitive impairment in patients with cardiovascular disease

ii. For the RCT, to compare the proportion of patients who demonstrate improvement in cognitive test scores by 24 weeks between intervention and usual care arms.

Secondary objectives:

i. To evaluate changes in neuropsychological domains (e.g. memory, processing speed), mental health, frailty, and quality of life over time.

ii. To study the association between cognitive status and cardiovascular treatment plan categories.

02

Conditions studied

  • Cognitive Impairment

Keywords

  • cognitive assessment
  • cardiovascular disease
03

In context

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

National Heart Centre Singapore is the lead sponsor of 63 studies on the registry; 18 are open to participants now.

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

04

Who can participate

Ages eligible
21 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Main Study:

  • Age ≥ 21 years.
  • Able and willing (or via legally acceptable representative, LAR, where appropriate) to provide .

RCT Sub-Study (Mild cognitive impairment (MCI) arm):

  • Meets main study criteria.
  • Mild cognitive impairment defined by: (i) (MoCA) \<26 but ≥21; and/or (ii) impairment in at least one domain on standardized neuropsychological testing and/or (iii) MMSE \<28 but ≥24.

Exclusion criteria

Exclusion Criteria:

  • Neurodegenerative disorders or major psychiatric illnesses that substantially impair cognition.
  • Terminal illness or advanced major organ disease limiting participation with expected survival of less than 1 year.
  • Severe depression, anxiety, or stress where participation may be inappropriate.
  • Any condition which, in the investigator's opinion, would compromise safety or study integrity.

Note: Pregnant and breast-feeding women may not take part in this study.

Terms in these criteria, in plain language(2)

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.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5,000 participants (estimated)

Study arms

  • No intervention
    Main (Observational) Cohort

    Required procedures during baseline visit: i. Blood pressure test ii. Biospecimen collection (Optional) iii. Musculoskeletal analysis iv. Memory test: MoCA and MMSE

  • Other
    Randomized Controlled Trial (RCT) R1 Cohort

    Baseline: 1. Cardiovascular measurements:- * Blood pressure test * Echocardiography * Electrocardiography 2. Biospecimen collection 3. Six-minute walk test 4. Musculoskeletal Analysis 5. Cardiopulmonary exercise test (CPET) / Treadmill test (TMX) 6. Magnetic resonance imaging 7. Neuropsychological assessment During Intervention: 12 exercise sessions and 12 cognitive sessions Post-Intervention: 1. Same procedures as Baseline except CPET / TMX 2. Post-intervention questionnaire 3. Qualitative interview (Optional)

    Other: Structured cognitive and cardiovascular interventions

  • No intervention
    Randomized Controlled Trial (RCT) R2 Cohort

    Baseline: 1. Cardiovascular measurements:- * Blood pressure test * Echocardiography * Electrocardiography 2. Biospecimen collection 3. Six-minute walk test 4. Musculoskeletal Analysis 5. Cardiopulmonary exercise test (CPET) / Treadmill test (TMX) 6. Magnetic resonance imaging 7. Neuropsychological assessment Post-Intervention: 1. Same procedures as Baseline, except CPET / TMX 2. Post-intervention questionnaire

Interventions

  • OtherStructured cognitive and cardiovascular interventions

    The intervention arm (RCT R1 cohort) will receive a 24-week multi-component program combining cardiac rehabilitation instruction, cognitive stimulation via a hybrid hospital and home-based telehealth platform.

06

What researchers measure

Primary outcomes

  1. Primary RCT Outcome

    Proportion of participants demonstrating clinically meaningful improvement in cognitive function at 24 weeks, defined as a pre-specified increase in standardized cognitive test scores.

    Time frame: 24 weeks

07

Study locations

1 of 4 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07829380
Lead sponsor
National Heart Centre Singapore
Responsible party
Sponsor
First posted
Sep 21, 2026
Start date
Aug 4, 2026
Primary completion
Dec 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Sep 21, 2026

Study contacts

Angela S. Koh, MBBS
Contact
angela.koh.s.m@singhealth.com.sg
+6567048961
Mee Yin Wong, BSc
Contact
wong.mee.yin@nhcs.com.sg
+6567042302

Oversight

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

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