Heart Failure and a Preserved Ejection Fraction

NCT00586833 | Completed

• 2 other identifiers: 07-001301CHF
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a cross sectional study comparing patients with HFpEF and age-matched, non-HF controls recruited from the community. This design will allow for determination of biologically relevant differences in baseline ventricular and vascular function, and importantly, differences in the ability to augment ventricular and vascular function dynamically during exercise stress, when symptoms of HF typically are first noted. The endpoint of exercise-reserve function is novel and has been little examined in the existing HFpEF literature.

Conditions

Heart Failure

Keywords

Heart Failure; Heart Failure, Diastolic; Dyspnea, Paroxysmal; Edema, Cardiac

Outcome Measures

Primary Outcomes (1)

• Contrast resting and exercise-induced changes in vascular stiffness, endothelial function, and afterload in patients with HFpEF to age-matched controls.

  Throughout single visit.

Secondary Outcomes (2)

• Determine how baseline and exercise-induced changes in the vascular parameters measured are related to LV systolic and diastolic functional reserve, cardiac output response, metabolic exercise performance, and changes in pulmonary cap

  Throughout single visit

• Determine if vascular and ventricular stiffness properties measured in specific aim 1 are associated with abnormal neurohormonal responses to exercise.

  Immediately pre and post exercise

Study Arms (3)

1

No CHF/HTN Never diagnosed with CHF and undergoing current treatment for HTN

Procedure: O2 consumption max bike test

2

CHF with HFpEF HFpEF Cases will be recruited from the community. Subjects will be largely drawn from an existing Mayo database examining all incident cases of HF in Olmsted County.

Procedure: O2 consumption max bike test

3 Healthy normal adults

No identifiable cardiac issues at time of exercise.

Procedure: O2 consumption max bike test

Interventions

O2 consumption max bike test PROCEDURE

Single visit exercise study

Also known as: Standard metabolic stress testing., Pulmonary Capillary Blood Volume., Plasma and Serum Neurohormone levels., Ventricular data determined from echo-Doppler., Vascular data obtained using a radial tonometry device

1; 2; 3 Healthy normal adults

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 Cases will be recruited from the community. Subjects will be largely drawn from an existing Mayo database examining all incident cases of HF in Olmsted County.3 There are currently \>350 pre-identified subjects with HFpEF from this study who may be eligible, which will greatly enrich the recruiting process. Control Subjects will be recruited from the community. Control subjects will be matched for age and gender to HFpEF subjects, but will have no history of HF hospitalization or significant exertional dyspnea suggestive of "preclinical" HF.

You may qualify if:

• Consultation by a cardiologist for HF in the past 1 year
• (HF rigorously defined by the modified Framingham criteria9),
• able to exercise on a treadmill

You may not qualify if:

• decompensated HF; significant valvular disease; infiltrative, restrictive, or hypertrophic cardiomyopathy; cor pulmonale or significant pulmonary limitation; unstable coronary disease; atrial fibrillation; pregnancy; inability to exercise or suspend vasoactive medicines for at least 24 hours

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood is drawn to evaluate BNP and cGMP pre and post exercise.

MeSH Terms

Conditions

Heart Failure; Heart Failure, Diastolic; Dyspnea, Paroxysmal; Edema, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Dyspnea; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Edema

Study Officials

• Barry A. Borlaug, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: April 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 14, 2010

Record last verified: 2010-10

Locations

US (1)