BuspiRon for chEmoreflex modulation and central Apnea treatment in Heart failure patients

Use of buspiron in chemioreflex modulation and central apnea treatment in heart failure patients (BREATH: BuspiRon for chEmoreflex modulation and central Apnea treatment in Heart failure patients). Phase II, monocentric, cross-over, duble dummy, randomized and controlled, pilot study. - BREATH

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005383-42-IT

Enrollment

Registered

2019-01-07

Start date

2016-05-19

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patient with central apneas syndrome and heart failure MedDRA version: 20.0 Level: LLT Classification code 10011949 Term: Decompensation cardiac System Organ Class: 100000004849 MedDRA version: 20.0 Level: HLT Classification code 10040978 Term: Sleep apnoeas System Organ Class: 100000004852

Interventions

Trade Name: Anxut 5 mg Pharmaceutical Form: Capsule, soft INN or Proposed INN: BUSPIRONE Current Sponsor code: BUSPIRONE Concentration unit: mg milligram(s) Concentration type: equal Concentration num

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age between 18 and 80 years; 2) Heart failure (diagnosed according to Framingham criteria) with a left ventricular dysfunction (ejection fraction-EF =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: 1) Participation in the previous 3 months to other clinical studies; 2) Pregnant, breast-feeding women or fertile women that do not follow and adequate contraception (every woman must consent to abstinence from sexual intercourse, or adopt any two of the following contraception measures considered efficacious as: bilateral tube ligation, male sterilization, use of hormonal contraceptives that inhibit ovulation, copper intrauterine devices; every barrier device must be used together with a spermicide cream); 3) Recent acute heart failure or acute coronary syndrome (in the last 3 months); 4) Chronic severe renal insufficiency (creatinin clearance 100 U/L and/or gamma GT > 150 U/L); 7) Major unstable psychiatric disorders and/or use of psychoactive agents and agents that can influence respiratory drive (ATC: N02A (opiates), N02CC (serotonin agonists), N03 (antiepileptic agents), N04A (anticholinergic agents), N04B (dopaminergic agents), N05 (psycholeptic agents), N06 (antidepressants), S01EC01 (acetazolamide), R03DA (xanthine), R03DB (xanthine and adrenergic agents); 8) Concomitant use of drugs that inhibit or induce hepatic metabolism, in light of buspiron hepatic metabolism; 9) History of drug or alcohol dependence; 10) Administration of any experimental drug within 30 days of the enrollment in the present study; 11) Active malignancies; 12) Known or suspected allergy to the drugs subjected to investigation or to one or more of the excipients; 13) Lactose intolerance; 14) Incapability to sign the informed consent form; 15) Closed angle glaucoma; 16) Miastenia gravis; 17) Hereditary galactose intolerance, lactase deficieny or glucose-galactose malabsorption; 18) Any other condition or disease that, to the investigator judgment, may interfere with the present study.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of buspiron effects on chemoceptive sensitivity to carbon dioxide (CO2) in heart failure patients with CO2 hypersensitivity;Secondary Objective: Evaluation of buspiron effects on the same patients on: 1) Nocturnal apneas; 2) Neurohormonal balance, with a specific focus on the adrenergic axis; 3) Sympathovagal balance, evaluated by means of the Holter ECG; 4) Exercise capacity, evaluated by means of the cardiopulmonary exercise test.;Primary end point(s): A difference of 0.5 of the hypercapnic ventilatory response (HCVR) compared to the placebo, assessed with the rebreathing technique, evaluated at day 1 and repeated at day 8, 15 and 22. Briefly, the patient breaths into a closed circuit, with progressive increase of CO2, while stabilizing FiO2 by means of external oxygen flow. Carbon dioxide sensitivity is expressed as the linear regression slope between ventilation and the end tidal CO2 (et-CO2) (additional technical details in the protocol);Timepoint(s) of evaluation of this end point: Day 1, 8, 15 and 22.	—

Measure

Time frame

Main Objective: Evaluation of buspiron effects on chemoceptive sensitivity to carbon dioxide (CO2) in heart failure patients with CO2 hypersensitivity;Secondary Objective: Evaluation of buspiron effects on the same patients on: 1) Nocturnal apneas; 2) Neurohormonal balance, with a specific focus on the adrenergic axis; 3) Sympathovagal balance, evaluated by means of the Holter ECG; 4) Exercise capacity, evaluated by means of the cardiopulmonary exercise test.;Primary end point(s): A difference of 0.5 of the hypercapnic ventilatory response (HCVR) compared to the placebo, assessed with the rebreathing technique, evaluated at day 1 and repeated at day 8, 15 and 22. Briefly, the patient breaths into a closed circuit, with progressive increase of CO2, while stabilizing FiO2 by means of external oxygen flow. Carbon dioxide sensitivity is expressed as the linear regression slope between ventilation and the end tidal CO2 (et-CO2) (additional technical details in the protocol);Timepoint(s) of evaluation of this end point: Day 1, 8, 15 and 22.

—

Secondary

Measure	Time frame
Secondary end point(s): Evaluation of the effects of the drug on exercise performance with the cardiopulmonary stress test by means of a cycle-ergometer.;Timepoint(s) of evaluation of this end point: Evaluation at day 0 and repeated at day 7 and day 21.	—

Countries

Italy

Contacts

Public ContactUOC Medicina Cardiovascolare

Fondazione Toscana Gabriele Monasterio

farmacisti@ftgm.it0585493507

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026