Exercise Training to Improve Cardiopulmonary Hemodynamics in Heart Failure Patients

NCT ID: NCT04909008

Last Updated: 2025-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-12-01

Brief Summary

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This research study is being done to find out if exercise therapy can help improve the heart function, overall health, and quality of life of patients with pulmonary hypertension caused by heart failure.

Detailed Description

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The purpose of this research is to see if taking part in structured exercise training will improve the ability to exercise, the function of the heart, and the function of the blood vessels that supply the lungs in patients with heart failure and pulmonary hypertension. After enrollment all patients will complete exercise testing. Patients will be randomized to either 10 weeks of exercise training (3 times per week) or will continue standard medical care. All patients will undergo detailed exercise testing before and after the intervention.

Conditions

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Heart Failure Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control trial
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Exercise Training

Two sets of exercise testing (before and after) 10 weeks of supervised exercise training (3 sessions per week) at Mayo Clinic Florida.

Group Type EXPERIMENTAL

Exercise Training

Intervention Type OTHER

10 weeks of supervised exercise training, 3 sessions per week at the cardiac rehab clinic at Mayo Clinic Florida.

Control Groups

Two sets of exercise testing while continuing with standard medical care in between.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise Training

10 weeks of supervised exercise training, 3 sessions per week at the cardiac rehab clinic at Mayo Clinic Florida.

Intervention Type OTHER

Other Intervention Names

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Cardiac Rehab

Eligibility Criteria

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Inclusion Criteria

* NYHA functional class I-IIIb.
* LVEF \< 40%.
* Clinically-stable for \> 3 months \[no change in disease status or medication\].
* Willing and able to provide written informed consent and perform cycle-ergometer or treadmill based exercise.

Exclusion Criteria

* NYHA class IV HF.
* Diagnosis of diastolic HF.
* Comorbidities such as obesity (BMI \>36), uncontrolled systemic hypertension, type 2 diabetes, and COPD (FEV1 \<50%).
* Musculoskeletal or other conditions that would limit exercise participation.
* Pregnant or nursing women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Florida Heart Research Institute

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Bryan Taylor

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bryan J Taylor, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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20-011347

Identifier Type: -

Identifier Source: org_study_id

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