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RecruitingNCT06299436HALT-RHFUpdated Jan 12, 2026

Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure

An observational study in Heart Failure With Reduced Ejection Fraction, Pulmonary Hypertension and Right Heart Failure Due to Left Heart Failure, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-01-12.

Sponsored by Johns Hopkins University · Observational

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 90 Years
Sex
All
01

Study summary

Right ventricular (RV) failure is recognized to worsen patient outcomes in the setting of heart failure with reduced ejection fraction (HFrEF)-related pulmonary hypertension (PH), yet the investigators fall short in trying to identify and treat it. The current proposal will (1) determine the best clinical indicators of intrinsic RV myocyte contractile failure in humans with HFrEF-PH, (2) clarify underlying mechanisms, and (3) test novel treatments on RV myocytes. The long-term goal of this proposal will be to better identify and treat RV failure in humans suffering from HFrEF-PH.

Read the detailed description

This proposal aims to improve diagnosis and mechanistic understanding of right ventricular (RV) myocyte dysfunction in heart failure patients with reduced ejection fraction and pulmonary hypertension (HFrEF-PH). RV dysfunction is common and hastens poor outcomes in HFrEF-PH. Despite its importance, clinical ability to characterize it remains imprecise. This frustrates prognostic and therapeutic efforts in many scenarios, such as the prediction of RV failure following left ventricular assist device. In 2023, the investigators reported that RV myocyte contractile reserve indices, such as calcium-activated isometric tension and length-dependent active tension, are reduced in RV tissue of explanted end-stage human HFrEF-PH hearts. Notably, clinical indices correlated modestly with calcium-activated tension but completely failed to capture depression of length-dependent tension, the latter a key contributor to RV Frank-Starling reserve. This deficiency highlights one possible reason why clinical indices fail to identify RV failure. A shortcoming of this work was its study of end-stage disease, and the investigators believe better clinical correlates of myocyte dysfunction from earlier-stage disease may provide more insight at a time point when interventions would still be helpful. The investigators central hypothesis is that clinical identification of RV myocyte disease in HFrEF-PH requires measuring RV contractile reserve, as is elicited during exercise. The investigators prior study of primary PH patients supports this, and new preliminary data in patients with PH secondary to heart failure does so as well. Delving deeper, the investigators recently reported a novel deficiency of the sarcomere thick filament in HFrEF-PH RV myocytes, driven by an excess of myosin in the inactive super-relaxed state that hinders its recruitment to form cross-bridges by either calcium- or stretch-activation. The latter is important as it is not seen in small rodents, and only recently reported in pigs, thus newly linking super-relaxed myosin to RV myocyte and chamber reserve in humans. The investigators new phospho-proteomic data shows less myosin binding protein-C phosphorylation yet more phosphorylation of several sarcomere Z-disc proteins, and supports the potential role based on kinase and phosphatase modifications.

This proposal was spawned by these recent findings. The investigators objectives are to: (1) identify clinical indices that capture RV myocyte reserve failure in earlier-to-mid stage HFrEF-PH; (2) uncover mechanisms of myocyte length-dependent contractile depression; and (3) test sarcomere-activating drugs that might prove useful for HFrEF-PH RV failure. The investigators combine state-of-the-art pressure-volume loop and clinical assessments of RV chamber function with phenotyping of the myocyte contractile apparatus. The investigators further explore a new role of super-relaxed myosin in depressed myocyte reserve. The proposal leverages my translational and basic muscle expertise developed over the past several years with K23 support, and a stellar collaborative team. Its objectives align with NHLBI strategic visions for the RV and advanced HF. There are three Specific Aims:

Aim 1. Test whether clinical measures of RV exercise reserve better reflect RV myocyte contractile dysfunction in earlier-stage HFrEF-PH. HFrEF patients referred for right heart cath undergo a well-established protocol at Johns Hopkins to assess clinical hemodynamic and echocardiographic RV indices alongside RV pressure-volume loop parameters at rest and with supine bicycle exercise. RV endomyocardial biopsies are obtained, and isolated myocytes permeabilized to assess contractile mechanics and calcium- and length-activated tension. The investigators then test whether clinical RV exercise reserve parameters will more sensitively reflect RV myocyte contractile reserve limitations than commonly used resting measures of RV function.

Aim 2. Determine roles and identities of phosphorylation mediators of reduced HFrEF-PH RV myocyte length-dependent reserve. New phospho-proteomic data finds protein kinase A (PKA)-hypophosphorylation of thick filament proteins and hyperphosphorylation of Z-disc scaffold proteins in HFrEF-PH RV myocardium. PKA incubation increases myocyte length-dependent tension, while protein phosphatase 2a (which does not reverse PKA changes) improves calcium-activated tension. The investigators test the relevance to myocyte contractile reserve failure in HFrEF-PH in permeabilized RV myocytes by selective kinase and phosphatase incubation, then selectively mutate high-value phospho-modified sites to test the role in length-dependent activation.

Aim 3: Determine whether newer sarcomere-activating drugs restore HFrEF RV myocyte length-dependent tension. Two sarcomere-activating drugs are tested in HFrEF-PH RV myocytes: danicamtiv and CK-136, which should augment length-dependent tension better than similar, previously tested drugs. The investigators determine impact on skinned myocyte contractile reserve, then test if the clinical RV reserve indices identified in Aim 1 can predict impact on individual HFrEF-PH RV myocytes from the same patient.

Expected outcomes: the investigators will identify optimal clinical indices of RV reserve failure in HFrEF-PH, clarify myocyte mechanisms of length-dependent reserve, and test novel RV drugs. Findings will impact RV failure due to HFrEF-PH and should apply to its other causes as well. The investigators research team has exceptional expertise in translational RV phenotyping and muscle biophysics and is uniquely poised to deliver on this proposal.

02

Conditions studied

  • Heart Failure With Reduced Ejection Fraction
  • Pulmonary Hypertension
  • Right Heart Failure Due to Left Heart Failure

Keywords

  • right heart failure
  • heart failure
  • cardiomyopathy
  • pulmonary hypertension
  • heart failure with reduced ejection fraction
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's planned enrollment of 50 is below the median of 116 across 386 observational studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will include patients who have heart failure with reduced ejection fraction, defined by a left ventricular ejection fraction less than or equal to 40-50%.

Inclusion criteria

  • Adult patients aged between 18 and 90 years of age
  • Diagnosed with heart failure with reduced ejection fraction (LV ejection fraction ≤ 40-50%)
  • Can safely hold direct oral anticoagulant (DOAC) vitamin K antagonist (VKA) for 48 hours prior to the procedure

Exclusion criteria

Exclusion Criteria:

  • Unable to interrupt VKA anticoagulation
  • Point of care International Normalized Ratio (INR) > 1.5
  • Pregnant patients
  • Acute hospitalization or decompensation within 2 weeks prior to study date
  • Participation in a study involving an investigational drug within 4 weeks prior to study date
  • Inability to lie flat in the supine position
  • Symptomatic hemodynamic instability at rest or during the procedure
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Diagnostic accuracy based on Area Under Curve (AUC)

    Diagnostic accuracy (AUC), as determined by combination of sensitivity and specificity, of multiple clinical metrics will be compared to determine which best identifies underlying right ventricular myocyte contractile dysfunction.

    Time frame: 5 years

Secondary outcomes

  1. Percentage improvement in ex vivo right ventricular tissue sample

    Percentage improvement is defined as the percent difference in ex vivo right ventricular tissue sample myocyte contractility before and after experimental exposure to sarcomere-activating agent. Note this testing occurs on tissue samples, not in human subjects.

    Time frame: 5 years

  2. Predictive capacity (based on likelihood ratio)

    Combining primary and secondary outcomes, the predictive capacity of clinical metrics will be determined for anticipating a response to sarcomere-activating agent.

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Johns Hopkins Hospital
    Baltimore, Maryland 21287, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06299436
Lead sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Mar 7, 2024
Start date
Dec 10, 2024
Primary completion
Mar 31, 2029 (estimated)
Completion
Mar 31, 2029 (estimated)
Last update
Jan 12, 2026

Study contacts

Steven Hsu, MD
Contact
steven.hsu@jhmi.edu
410-502-0955
Steven Hsu, MD
principal investigator · Johns Hopkins School of Medicine

Oversight

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

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