Comparison of the Prediction Derived by the Cardiovascular Performance Reserve Index With the Clinical Evaluation

• Conditions: Healthy; Heart Failure

• Registration Number: NCT01796704
• Lead Sponsor: Clalit Health Services

Brief Summary

The study hypothesizes that an assumed cardiovascular performance reserve is physiologically detectable.

High reserve at rest characterizes a healthy person while low reserve at rest characterizes low functional capacity e.g. heart failure. The lower the reserve the severer the morbidity.

The reserve may be estimated through CVRI (cardiovascular reserve index) which is computed by an algorithm composed of physiological measurements taken during the patient visit.

In this study the investigators evaluate CVRI capability in prediction of functional capacity in comparison with the clinical evaluation during the same visit.

Detailed Description

The study hypothesizes that an assumed cardiovascular performance reserve is physiologically detectable and continuously monitored by a physiological control (reserve control)not yet discovered.

High reserve at rest characterizes a healthy person while low reserve at rest characterizes low functional capacity e.g. heart failure. The lower the reserve the severer the morbidity.

The reserve is decreased reversibly with aerobic activity and may reach an exhaustion threshold in which the assumed reserve control induces a reversible fatigue and dyspnea which dissolve once the activity decreased.

The reserve may be estimated through CVRI (cardiovascular reserve index) which is computed by an algorithm composed of physiological measurements taken during the patient visit (composed of blood pressure, heart rate, respiratory rate, central venous pressure or its estimation, weight, height and gender.

In this study the investigators evaluate CVRI capability in prediction of functional capacity in comparison with the clinical evaluation during the same visit (cross sectional comparison).

Study Timeline

• Status Verified: 2012-10
• Study First Submitted: 2013-01-29
• Study Start: 2013-02
• Study First Submitted QC: 2013-02-21
• Last Update Submitted: 2013-02-21
• Study First Posted: 2013-02-22
• Last Update Posted: 2013-02-22
• Primary Completion: 2013-12
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• adult informed consent

Exclusion Criteria

• an emergency case

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cardiovascular reserve index	1 day	CVRI

Trial Locations

Locations (1)

Independent physician Clinic Clalit Health Services; 🇮🇱 Tel Aviv, Israel