VoIce Changes and Heart Failure

NCT02555904 | Unknown

• 1 other identifier: 2015P000986
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an observational, single center study to evaluate if acoustic and accelerometer-based measures of voice and speech have sufficient precision to detect a change in lung fluid status for patients with confirmed acute heart failure syndrome with pulmonary congestion. The study shall be conducted in concordance with the United States FDA regulations for a non-significant risk study. Patients admitted for acute heart failure syndrome with pulmonary congestion with an expected stay greater than 3 to 4 days, who are willing and able to sign an informed consent, and who meet all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study. Results of this study will evaluate the sensitivity of voice and speech measures in detecting changes in lung fluid status in a symptomatic population. Up to 12 subjects will be enrolled to comparatively evaluate the voice outcome measures in this pilot study.

Conditions

Heart Failure; Voice; Congestion; Pitch

Outcome Measures

Primary Outcomes (1)

• Relationship between change in pitch and change in total body water

  correlation of change in fundamental frequency with change in weight

  10 days

Secondary Outcomes (2)

• relationship between change in pitch and change in NTproBNP

  10 days

• correlation in change in pitch with change in dyspnea visual analog scale (DVAS)

  10 days

Study Arms (1)

Heart failure syndrome & pulmonary congestion

Patients who are admitted for inpatient management with acute heart failure syndrome with pulmonary congestion who require intravenous diuretics are potential candidates for the study and shall be screened for suitability based on the inclusion and exclusion criteria.

Eligibility Criteria

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

Study Population

Patients with acute heart failure syndromes admitted for inpatient management meeting inclusion and exclusion criteria will be asked to consent for the study.

You may qualify if:

• \> 18 years
• Prior diagnosis of heart failure with daily use of loop diuretic
• Must be identified within 48 hrs of admission
• Diagnosis of acute Congestive Heart Failure (CHF) as defined by at least one symptom or one clinical sign
• Believed to be \> 10 lbs above target weight
• Anticipated need for iv loop diuretic for at least 48 hrs

You may not qualify if:

• Inability to perform VA
• Respiratory infection
• Significant pulmonary disease requiring the use of inhaler bronchodilators or steroids
• Anticipate need for vasoactive agent or ultrafiltration
• Systolic BP \< 90 mmHg
• Serum Cr \> 3 on admission or requirement for dialysis
• Hemodynamically significant arrhythmias
• Acute Coronary Syndrome (ACS) within 4 weeks
• Hypertrophic Obstructive Cardiomyopathy (HOCM)
• Severe stenotic valve disease
• Complex congenital heart disease
• Sepsis
• Active smoking within 1 year
• O2 saturation less than 92% on room air
• History of diagnosed vocal cord pathology / dysfunction

Sponsors & Collaborators

• Massachusetts General Hospital: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Marc Semigran, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maureen Daher, RN

CONTACT

MDAHER@mgh.harvard.edu

Marc Semigran, MD

CONTACT

MSEMIGRAN@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician investigator

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: September 22, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 22, 2015

Record last verified: 2015-09