ClinicalTrials.Veeva

Menu

Mechanisms in Heart Failure With Normal EF (HFpEF)

Mayo Clinic logo

Mayo Clinic

Status

Completed

Conditions

Heart Failure

Treatments

Procedure: RHC with VO2 consumption

Study type

Observational

Funder types

Other

Identifiers

NCT00587808
07-005202
HFpEF

Details and patient eligibility

About

The guiding hypotheses are that (1) mechanisms in addition to diastolic dysfunction, while normal at rest, are compromised with stress, leading to symptoms of HF, and (2) that an increased proportion of the increase in LV diastolic pressures seen in HFpEF is mediated via exaggerated pericardial/right heart-LV coupling (restraint).

Full description

Nearly half of all patients with heart failure have a preserved ejection fraction (HFpEF)1-3. This group is increasing in prevalence, has similar morbidity and mortality to systolic HF, and, despite increasing awareness of the healthcare burden, is without proven treatments1. This is related largely to a limited understanding of the basic mechanisms causing the disease3. Recent studies have added to contemporary understanding, but the pathophysiology remains controversial and incompletely understood4-8. A limitation of most prior studies is that the noninvasive measurements employed are merely surrogates for gold standard, invasive hemodynamic assessment9. There is general consensus that HFpEF patients have increased left ventricular filling pressures (LVDP) and relatively normal systolic function at rest5,8,10, but two critical questions remain: what causes the increase in LVDP, and, are there important deficits in the cardiovascular response to exercise stress in HFpEF patients3,4? The current study will resolve these questions by performing comprehensive hemodynamic analysis in HFpEF patients referred to the cardiac cath lab, compared to age and gender matched controls without HF. LV systolic, diastolic, and vascular function will be examined at rest and during graded supine exercise at fixed and varied preload to definitively characterize both baseline differences and discrepancies in cardiovascular reserve function that only become apparent during stress, when HFpEF patients typically become symptomatic11. This study will yield valuable information describing the roles for systolic, diastolic and pericardial abnormalities in the pathogenesis of HFpEF, providing critical preliminary data upon which better targeted therapeutic trials of this common disorder can be based.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age>18, EF≥50% at echocardiography within 6 months, referred for cath. HFpEF subjects

Exclusion criteria

  • Patients with: any medical conditions that would limit study participation, pregnancy, myocardial infarction within 30 days of enrollment, hemodynamically significant valvular disease, HF due to thyroid disease, myocarditis, restrictive or hypertrophic cardiomyopathy, cor pulmonale (PVR>5 Wood units with RV dysfunction), LV thrombus, atrial fibrillation or other persistent irregular rhythm, dyspnea felt predominantly due to pulmonary disease, significant coronary artery stenoses (>70%, or 50-70% with FFR<0.8) or other abnormalities detected during the clinical catheterization procedure which require revascularization or other directed therapy.

Trial design

14 participants in 2 patient groups

HFpEF
Description:
Patients with a history of HFpEF
Treatment:
Procedure: RHC with VO2 consumption
control
Description:
Patients with a without a history of CHF
Treatment:
Procedure: RHC with VO2 consumption

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems