Mechanisms in Heart Failure With Normal EF

NCT00587808 | Completed

• 2 other identifiers: 07-005202HFpEF
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Heart Failure

Keywords

Heart Failure; Heart Failure, Diastolic; Stroke Volume

Outcome Measures

Primary Outcomes (1)

• Specific Aim 1. Elucidate the relative roles of impaired ventricular systolic, diastolic, and vascular reserve functions during supine exercise in HFpEF

  during catheterization

Secondary Outcomes (1)

• Specific Aim 2. Determine whether resting and exercise-induced increases in LV diastolic pressures are related to exaggerated right-left heart coupling and to increased afterload.

  during cardiac catheterization

Study Arms (2)

HFpEF

Patients with a history of HFpEF

Procedure: RHC with VO2 consumption

control

Patients with a without a history of CHF

Procedure: RHC with VO2 consumption

Interventions

RHC with VO2 consumption PROCEDURE

All pressure-volume data is acquired at 250 Hz and stored on the Leycom system for offline analysis. Volume data will be calibrated using the most recent EF from echocardiogram and stroke volume from the Fick method. Measured O2 consumption will be utilized along with sampling of SVC and arterial blood oximetry to determine cardiac output at rest and during exercise

HFpEF; control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HFpEF subjects (NYHA class ≥II) defined by modified Framingham criteria4 (2 major or 1 major + 2 minor): Major criteria: paroxysmal nocturnal dyspnea or orthopnea, jugular distension or venous pressure\>16 mmHg, rales or pulmonary edema, cardiomegaly, hepatojugular reflex, weight loss\>4.5 kg in response to diuretics, BNP\>400; Minor criteria: ankle edema, nocturnal cough, exertional dyspnea, pleural effusion, HR\>120, hepatomegaly, vital capacity\<2/3 normal, BNP\>200, LA volume index\>40cc/m2.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Heart Failure; Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Barry A. Borlaug, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: November 1, 2007
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 7, 2012

Record last verified: 2011-05

Locations

US (1)